NCT01957410.

Study name	An open‐label and double‐blind study to investigate evoked potentials as markers of ketamine‐induced cortical plasticity in participants with major depressive disorder
Methods	To evaluate if somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) obtained with electroencephalography (EEG) and electromyography (EMG) can be used to detect changes in cortical plasticity in responders to a single IV infusion of ketamine as compared to non‐responders Allocation: randomised Endpoint classification: safety/efficacy study Intervention model: parallel assignment Masking: double‐blind (participant, investigator, outcomes assessor) Primary purpose: treatment
Participants	Inclusion criteria Patient must be medically stable Patient must meet Diagnostic and Statistical Manual of Mental Disorders ‐ Fourth Edition (DSM‐IV) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI) Patient must have had an inadequate response to at least 2 antidepressants, one of which is in the current episode of depression Patient must have an Inventory of Depressive Symptomatology 30‐item Clinician‐rated (IDS‐C30) total score ≥ 34 at Screening and Day ‐1 Women must be post‐menopausal, surgically sterile, or, if heterosexually active, practicing a highly effective method of birth control Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug Exclusion criteria Patient has current signs and/or symptoms of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbances Patient has a primary DSM‐IV diagnosis of current (active) generalised anxiety disorder (GAD), panic disorder, obsessive compulsive disorder (OCD), post‐traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa Patient has a current diagnosis of bipolar disorder, mental retardation, or cluster b personality disorder (e.g., borderline personality disorders, antisocial personality disorder, etc) Patient has a current or prior diagnosis of a psychotic disorder or MDD with psychosis Patient has not responded to treatment with electroconvulsive therapy (ECT) in the current episode of depression Patient has suicidal ideation with intent to act, or has homicidal ideation/intent, during Screening phase per Investigator's clinical judgment Patient has any significant primary sleep disorder
Interventions	Ketamine versus placebo
Outcomes	Primary outcome measures: Comparison of change from baseline to 4 hr post‐dose on Day 1 in somatosensory evoked potential amplitudes (SEPs) between ketamine responders and ketamine non‐responders. Time frame: baseline and 4 hours post‐dose on Day. [Designated as safety issue: No]. SEPs are the electrical signals generated by the nervous system in response to somatosensory stimuli ‐ typically through electrical stimulation of the median nerve. SEPs are read on the skull with electroencephalography (EEG). SEPs will be carried out as described by Cornwell and colleagues (Cornwell 2012) with the exception that instead of using magnetoencephalography SEPs will be recorded using a 64‐channel EEG system. Identical procedures will be employed prior to and after study drug administration
Starting date	February 2014
Contact information	jnj.ct@sylogent.com
Notes	NCT01957410